View all courses

Risk Analysis Model for Management of Quality Risk

Risk Analysis Model for Management of Quality Risk


The pharmaceutical industry relies on limits that have been predetermined through research to evaluate the quality of products, raw materials, and by-products at every phase of the manufacturing process. This course introduces you to the concept of Quality Risk Management (QRM) which must be applied all through the manufacturing process, even at the level of raw material suppliers to ensure that the final pharmaceutical products and devices are safe and effective for patients’ use. Risk analysis is a necessary component of QRM as it unearths hidden issues in the manufacturing process.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.






  • Background and Scope
  • Quality Risk Management (QRM)
  • Aim of the Quality Risk Management (QRM) to the Pharmaceutical Industry
  • Principles of Quality Risk Management


Lesson 1: Purpose of Quality Risk Management (QRM)


  • Quality Target Product Profile (QTPP)
  • Finished Pharmaceutical Product (FPP)
  • Critical Process Parameters (CPPs)
  • Critical Quality Attributes (CQAs)


Lesson 2: Quality of Risk Management Process


  • Personnel Involved in QRM
  • Product and Process Knowledge
  • Risk Assessment
  • Maintenance of Risk Assessment Records
  • Risk Control
  • Risk Review
  • Verification of Quality Risk Management Process and Techniques
  • Communication and Documentation of Risks


Lesson 3: Pharmaceutical Applications of QRM


  • Responsibilities
  • QRM Application During Product Development
  • Use of QRM in Commercial Manufacturing
  • Integrating QRM with Critical Components of the Quality System
  • Application of QRM in Product Manufacture


Lesson 4: QRM Considerations for Medicines Regulatory Authorities


  • QRM Application to Inspection Strategy


Lesson 5: Risk Management Tools


Lesson 6: Project Risk Analysis and Management (PRAM)


  • Qualitative Risk Analysis
  • Quantitative Risk Analysis
  • Benefits of PRAM








Risk Analysis Model for Management of Quality Risk
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

$150 $150

Buy now

General info:

Duration :



Skill level:




Final exam:


Certificate of Completion:



This course provided answers to questions from the team regarding the necessity for risk management at every stage of the manufacturing process. We are convinced that this new knowledge will bring forth more diligence.

Patcharee K


Director of Compliance

$150 $150

Buy now
Risk Analysis Model for Management of Quality Risk

See a preview of this course

No video yet for this course

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h